Long-Term Longitudinal QoL in Patients Undergoing EEA

Recruiting

• Conditions: Chordoma; Rathke Cleft Cysts; Pituitary Tumor; Esthesioneuroblastoma; Craniopharyngioma; Encephalocele; Meningioma; Chondrosarcoma

• Registration Number: NCT04087902
• Lead Sponsor: Ohio State University

Brief Summary

This is a prospective longitudinal study to access postoperative 2-year quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base.

Detailed Description

This is a prospective single-institution longitudinal study to access quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base. Patients will be followed before surgery and up to twenty-four months post-surgery. The primary goal of the study is to assess the alterations to patient quality of life following endoscopic endonasal surgery using modern sinonasal reconstruction techniques. Secondary goals are to better understand the time course of normal healing and patient/procedural risk factors associated with poorer quality of life outcomes.

Study Timeline

• Study Start: 2019-07-16
• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-22
• Last Update Posted: 2023-10-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patient is scheduled to undergo endoscopic endonasal surgery. Multiple, staged surgeries are not exclusionary
• 18 years of age or older
• The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent

Exclusion Criteria

• Patient is a prisoner
• Patient is not English speaking
• Patient is not expected to survive until the 2-year follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PROMIS-29 quality of life outcome measures for patients undergoing endoscopic endonasal surgeries.	24-months post-operatively	This study aims to better understand the long-term overall quality of life of patients undergoing endoscopic endonasal surgery using modern sinonasal reconstruction techniques. The PROMIS-29 metric, an overall quality of life metric, will be used to better understand quality of life for patients undergoing this procedure.

Secondary Outcome Measures

Name	Time	Method
ASK Nasal-12 questionnaire used to measure normal time of healing for patients undergoing endoscopic endonasal surgery	24 months post-operatively	This study aims to better understand the overall nose function in patients undergoing endoscopic endonasal surgery using modern sinonasal techniques. The ASK Nasal-12 metric is designed to evaluate nose overall nose function such as post-nasal drip, ability to smell, and pain.
Number of patients with long-term quality of life risk factors using PROMIS-29	24 months post-operatively	This study aims to better understand the number of long-term risk factors for patients undergoing endoscopic endonasal surgeries using modern sinonasal reconstruction techniques. This will be done using the PROMIS-29 metric along with patient data.
Number of patients with long-term procedural comorbidities using ASK-Nasal 12.	24 months post-operatively	This study aims to better understand the number of long-term comorbidities for patients undergoing endonasal endoscopic surgeries using modern sinonasal reconstruction techniques. This will be done using the ASK-Nasal 12 metric along with patient data.

Trial Locations

Locations (1)

Ohio State University; 🇺🇸 Columbus, Ohio, United States